Rich Phoebe, Vlahovic Tracey C, Joseph Warren S, Zane Lee T, Hall Steve B, Gellings Lowe Nicole, Adigun Chris G
Oregon Dermatology and Research, Portland, USA.
Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania, USA.
Cutis. 2017 Oct;100(4):259-264.
There currently are 3 topical agents approved by the US Food and Drug Administration (FDA) to treat onychomycosis: tavaborole, efinaconazole, and ciclopirox. The phase 3 clinical trial designs for these treatments and their notable differences make it difficult for clinicians to interpret the data into clinical practice. For example, the primary end point predominantly used to assess efficacy in all the trials is complete cure, defined as no involvement of the nail plus mycologic cure; also, a notable number of patients fail to achieve a complete cure despite clear improvement in the nail. Despite close similarities in the end points and overall design of the clinical trials used for these agents, differences in design are notable, including the age range of participants, the range of mycotic nail involvement, the presence/absence of tinea pedis, and the nail trimming/debridement protocols used. The differences in clinical trial designs for the 3 FDA-approved topical agents and the lack of head-to-head studies makes efficacy interpretation and comparison inappropriate. This article reviews the phase 3 clinical trials that led to FDA approval of these agents, focusing on their similarities and differences.
目前，美国食品药品监督管理局（FDA）批准了3种用于治疗甲癣的外用药物：他伏硼酸盐、艾氟康唑和环吡酮。这些治疗方法的3期临床试验设计及其显著差异使得临床医生难以将数据应用于临床实践。例如，所有试验中主要用于评估疗效的主要终点是完全治愈，定义为指甲未受累且真菌学治愈；此外，尽管指甲有明显改善，但仍有相当数量的患者未能实现完全治愈。尽管这些药物的临床试验终点和总体设计非常相似，但设计上的差异也很显著，包括参与者的年龄范围、真菌性指甲受累范围、足癣的有无以及所采用的指甲修剪/清创方案。3种FDA批准的外用药物的临床试验设计差异以及缺乏直接对比研究使得疗效解释和比较变得不合适。本文回顾了导致FDA批准这些药物的3期临床试验，重点关注它们的异同。
